Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
AFFIRM
Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy
3 other identifiers
interventional
1,199
14 countries
246
Brief Summary
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2009
Longer than P75 for phase_3
246 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2009
CompletedFirst Posted
Study publicly available on registry
September 10, 2009
CompletedStudy Start
First participant enrolled
September 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2011
CompletedResults Posted
Study results publicly available
October 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2017
CompletedDecember 11, 2018
November 1, 2018
2 years
September 9, 2009
September 28, 2012
November 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).
During study period (up to 101 months)
Secondary Outcomes (9)
Radiographic Progression-free Survival
During DB phase (up to 24 months)
Time to First Skeletal-related Event
During DB Phase (up to 24 months)
Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Baseline up to 24 months
Time to Prostate-specific Antigen (PSA) Progression
Baseline and at every study visit from Week 13 while on study drug (up to 24 months)
Percentage of Participants With Pain Palliation
Baseline up to 24 months
- +4 more secondary outcomes
Other Outcomes (4)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Number of Participants With Clinically Significant Changes in Vital Signs
Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Number of Participants With Any Newly Clinically Significant Abnormal Finding in Electrocardiogram (ECG)
Baseline, up to the end of DB phase or unscheduled visit (up to 24 months)
- +1 more other outcomes
Study Arms (2)
Enzalutamide
EXPERIMENTALFormerly MDV3100
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Progressive prostate cancer
- Medical or surgical castration with testosterone less than 50 ng/dl
- One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow, hepatic, and renal function
- Able to swallow the study drug and comply with study requirements
- Informed consent
You may not qualify if:
- Metastases in the brain or active epidural disease
- Another malignancy within the previous 5 years
- Clinically significant cardiovascular disease
- Gastrointestinal disorder affecting absorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Astellas Pharma Inccollaborator
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.collaborator
Study Sites (249)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Premiere Oncology of Arizona
Scottsdale, Arizona, 85258, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211-1850, United States
USC Westside Prostate Cancer Center
Beverly Hills, California, 90211, United States
City of Hope
Duarte, California, 91010, United States
Cancer Center Oncology Medical Group
La Mesa, California, 91942, United States
LAC & USC Medical Center
Los Angeles, California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095-6984, United States
UCLA
Los Angeles, California, 90095, United States
c/o Prostate Oncology Specialist, Inc.
Marina del Rey, California, 90292, United States
North County Oncology Medical Clinic, Inc,
Oceanside, California, 92056, United States
Medical Oncology Associates - SD
San Diego, California, 92123, United States
Sharp Memorial Hospital Investigational Pharmacy
San Diego, California, 92123, United States
Sharp Rees-Stealy
San Diego, California, 92123, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
City of Hope Medical Group
South Pasadena, California, 91030, United States
Stanford Hospital and Clinics Research Pharmacy
Stanford, California, 94305, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Research Pharmacist
Aurora, Colorado, 80045, United States
University of Colorado Denver, Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
C/O: Thomas Ferencz R.Ph., BCOP
New Haven, Connecticut, 06510, United States
Yale University School of Med
New Haven, Connecticut, 06520, United States
George Washington University-Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Palm Beach Cancer Institute
Atlantis, Florida, 33462, United States
Palm Beach Cancer Institute
Palm Beach Gardens, Florida, 33410, United States
Palm Beach Cancer Institute
Wellington, Florida, 33414, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Peachtree Hematology-Oncology Consultants, P.C.
Atlanta, Georgia, 30318, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Chicago
Chicago, Illinois, 60637, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital (BWH)
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Siteman Cancer Center
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center-West County
Creve Coeur, Missouri, 63141, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110-1094, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Nevada Cancer Institute, an affiliate of the UC San Diego Health System
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico, 87109, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10021, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Pharmaceutical Research Services
Durham, North Carolina, 27710, United States
Portland VA Medical Center
Portland, Oregon, 97239, United States
UPMC Cancer Centers
McKeesport, Pennsylvania, 15132, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15237, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Grand Strand Urology
Myrtle Beach, South Carolina, 29572, United States
Tennessee Oncology, PLLC
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37087, United States
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37129, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5536, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, 37167, United States
Parkland Health and Hospital System
Dallas, Texas, 75235, United States
Texas Oncology, Sammons Cancer Center
Dallas, Texas, 75246, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Virginia Oncology Associates
Chesapeake, Virginia, 23320, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Virginia Cancer Institute
Mechanicsville, Virginia, 23116-1844, United States
Virginia Cancer Institute
Midlothian, Virginia, 23114, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Virginia Cancer Institute
Richmond, Virginia, 23235-4730, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
Virginia Oncology Associates
Williamsburg, Virginia, 23188, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)
Buenos Aires, AR, C1425AWC, Argentina
Instituto Oulton
Córdoba, Córdoba Province, X5000JJS, Argentina
Clinica Universitaria Privada Reina Fabiola
Córdoba, Córdoba Province, X5004FHP, Argentina
Policlinico Neuquen
Neuquén, Neuquén Province, 8300, Argentina
Policlinico Modelo de Cipolletti
Cipolletti, Río Negro Province, 8324, Argentina
Instituto de Investigaciones Clinicas Cipolletti
Cipolletti, Río Negro Province, R8324EMD, Argentina
Sanatorio Mapaci
Rosario, Santa Fe Province, S2000DTO, Argentina
Instituto de Oncologia y Especialidades Medicas
Rosario, Santa Fe Province, S2000KZE, Argentina
Hospital Italiano Garibaldi
Rosario, Santa Fe Province, S2001ODA, Argentina
Centro de Diagnostico Dr. Enrique Rossi
Buenos Aires, C1043AAS, Argentina
Centro de Diagnostico Dr. Enrique Rossi
Buenos Aires, C1425BEE, Argentina
North Coast Cancer Institute
Coffs Harbour, New South Wales, 2450, Australia
Sydney Cancer Centre
Concord, New South Wales, 2139, Australia
Mid North Coast Diagnostic Imaging
Port Macquarie, New South Wales, 2444, Australia
Port Macquarie Base Hospital Pharmacy
Port Macquarie, New South Wales, 2444, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444, Australia
Prince of Wales Hospital, Department of Medical Oncology
Randwick, New South Wales, 2031, Australia
The Tweed Hospital
Tweed Heads, New South Wales, 2485, Australia
PRP Diagnostic Imaging
Wentworthville, New South Wales, 2145, Australia
Sydney West Cancer Trials Centre, Department of Medical Oncology
Westmead, New South Wales, 2145, Australia
River City Pharmacy
Auchenflower, Queensland, 4064, Australia
Heart Care Partners
Auchenflower, Queensland, 4066, Australia
Icon Cancer Care Wesley
Auchenflower, Queensland, 4066, Australia
Icon Cancer Care Chermside
Chermside, Queensland, 4032, Australia
Southern X-Ray Chermside
Chermside, Queensland, 4032, Australia
Cancer Care Services
Herston, Queensland, 4029, Australia
Icon Cancer Foundation
Milton, Queensland, 4064, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4101, Australia
Mater Private Cardiology
South Brisbane, Queensland, 4101, Australia
Queensland X-Ray
South Brisbane, Queensland, 4101, Australia
XRadiology
Toowong, Queensland, 4066, Australia
Department of Medical Oncology
Adelaide, South Australia, 5000, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Peninsula Oncology Centre
Frankston, Victoria, 3199, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Sir Charles Gairdner Hospital, Department of Medical Oncology
Nedlands, Western Australia, 6009, Australia
60 Eleanor St
Footscray, 3011, Australia
Western Hospital
Footscray, 3011, Australia
The Royal Melbourne Hospital
Victoria, 3050, Australia
Krankenhaus der Barmherzigen Schwestern Linz
Linz, 4010, Austria
ISOTOPIX Ambulatorium fuer
Vienna, 1090, Austria
Medical University of Vienna
Vienna, 1090, Austria
Cliniques Universitaires Saint- Luc
Brussels, 1200, Belgium
AZ Sint- Lucas
Ghent, 9000, Belgium
VZW Jessa Ziekenhuis
Hasselt, 3500, Belgium
AZ Groeninge - Campus Kennedylaan
Kortrijk, 8500, Belgium
AZ Groeninge - Campus Sint Maarten
Kortrijk, 8500, Belgium
University Hospital Gasthuisberg
Leuven, 3000, Belgium
H.-Hartziekenhuis Roeselare-Menen vzw
Roeselare, 8800, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Tom Baker Cancer Centre - Holy Cross Site
Calgary, Alberta, T2S 3C3, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency, Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
B.C. Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, V8R 6V5, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L4M1, Canada
The Urology Specialists.
Montreal, Quebec, H2X 1N8, Canada
Imagerie medicale de la Capitale
Québec, Quebec, G1H 6P3, Canada
CHU de Quebec
Québec, Quebec, G1R 2J6, Canada
Centre de rechereche clinique et evaluative en oncologie
Québec, Quebec, G1R 3S3, Canada
Hospital San Jose
Santiago, Chile
Instituto Nacional del Cancer
Santiago, Chile
Centro Investigacion Clinica del Sur
Temuco, Chile
Instituto Oncologico
Viña del Mar, Chile
Centre Paul Papin
Angers, 49933, France
Institut Bergonie
Bordeaux, 33076, France
Centre Regional Francois Baclesse de lutte contre le cancer
Caen, 14076, France
Centre hospitalier de Cannes
Cannes, B.P. 264 - 06401, France
CHU Henri Mondor
Créteil, 94010, France
Centre Hospitalier Intercommunal Frejus-Saint Raphael
Fréjus, BP110 - 83608, France
Centre hospitalier departemental Vendee
La Roche-sur-Yon, 85925, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72000, France
Groupement Hospitalier Edouard Herriot - Pavillon V
Lyon, 69003, France
Centre Leon Berard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, BP 156 - 13273, France
Institut Curie
Paris, 75005, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Centre Hospitalier Lyon sud
Pierre-Bénite, 69495, France
CHU La Miletrie
Poitiers, 86021, France
Institut Jean Godinot
Reims, 51056, France
Centre Hospitalier
Saint-Etienne, 42030, France
Centre d'Investigation Clinique, (CIE3)
Saint-Etienne, 42055, France
Centre Rene Gauducheau
Saint-Herblain, 44805, France
Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, 42271, France
Hopital Foch
Suresnes, 92151, France
Institut Gustave Roussy
Villejuif, 94805, France
Universitaetsklinikum Aachen
Aachen, 52074, Germany
Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin
Berlin, 12200, Germany
Gemeinschaftspraxis Fuer Nuklearmedizin
Berlin, D- 10439, Germany
Radiologische Gemeinschaftspraxis
Berlin, D- 13055, Germany
FacharztzentrumInnere Medizin
Berlin, D-13055, Germany
Praxis Dr. Wolfgang Hoelzer
Berlin, D-13055, Germany
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126, Germany
Technical University Dresden
Dresden, 01307, Germany
Martini-Klinik am UKE GmbH
Hamburg, 20246, Germany
Roentgenpraxis
Hamburg, 22391, Germany
Urologische Gemeinschaftspraxis Poppenbuettel
Hamburg, 22399, Germany
Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie
Hanover, D-30625, Germany
Medizinische Hochschule Hannover
Hanover, D-30625, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Mannheim
Mannheim, 68167, Germany
Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie
Münster, D-48149, Germany
Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin
Münster, D-48149, Germany
Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie
Münster, D-48149, Germany
Abt.f.Diagnostische u. Interventionelle Radiologie
Tübingen, D-72076, Germany
Klinik fuer Urologie
Tübingen, D-72076, Germany
Nuklearmedizin
Tübingen, D-72076, Germany
Azienda Ospedaliero-Universitaria di Modena Policlinico
Via Del Pozzo 71, Modena, 41100, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, TO, 10043, Italy
Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona, 26100, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152, Italy
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
UMC St. Radboud
Nijmegen, 6525 GA, Netherlands
Erasmus MC
Rotterdam, 3075 EA, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
Grudziądz, 86-300, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny
Lodz, 93-509, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, 93-513, Poland
Wojewodzki szpital specjalistyczny im. Janusza Korczaka
Słupsk, 76-200, Poland
Hopelands Cancer Centre
Durban, 4001, South Africa
GVI Oncology
Port Elizabeth, 6045, South Africa
Sandton Oncology Centre
Sandton, 2199, South Africa
Hospital Universitario Germans Trias i Pujol
Badalona, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain
Radiodiagnostic Cetir Clinica Pilar
Barcelona, 08006, Spain
Hospital Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Madrid Norte Sanchinarro
Madrid, 28050, Spain
Clinica Universidad de Navarra
Pamplona, 31008, Spain
Bishops Wood Hospital
Northwood, Middlesex, HA6 2JW, United Kingdom
Mount Vernon Hospital
Northwood, Middlesex, HA6 2RN, United Kingdom
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Cancer Centre
Birmingham, B15 2TH, United Kingdom
Bristol Haematology & Oncology Centre
Bristol, BS2 8ED, United Kingdom
Bristol Royal Infirmary
Bristol, BS2 8HW, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
University College Hospital
London, NW1 2BU, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Northern Centre for Cancer Care
Newcastle upon Tyne, NE7 7DN, United Kingdom
Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
The Manor Hospital Oxford
Oxford, OX3 7RP, United Kingdom
Related Publications (14)
Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.
PMID: 35731340DERIVEDJoshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.
PMID: 35643841DERIVEDZhao JL, Fizazi K, Saad F, Chi KN, Taplin ME, Sternberg CN, Armstrong AJ, de Bono JS, Duggan WT, Scher HI. The Effect of Corticosteroids on Prostate Cancer Outcome Following Treatment with Enzalutamide: A Multivariate Analysis of the Phase III AFFIRM Trial. Clin Cancer Res. 2022 Mar 1;28(5):860-869. doi: 10.1158/1078-0432.CCR-21-1090.
PMID: 34965947DERIVEDTombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):288-295. doi: 10.1038/s41391-021-00447-9. Epub 2021 Sep 13.
PMID: 34518652DERIVEDArmstrong AJ, Al-Adhami M, Lin P, Parli T, Sugg J, Steinberg J, Tombal B, Sternberg CN, de Bono J, Scher HI, Beer TM. Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials. JAMA Oncol. 2020 Feb 1;6(2):217-225. doi: 10.1001/jamaoncol.2019.4636.
PMID: 31830211DERIVEDPoon DMC, Wong KCW, Chan TW, Law K, Chan K, Lee EKC, Lee C, Chan M; Hong Kong Society of Uro-Oncology (HKSUO). Survival Outcomes, Prostate-specific Antigen Response, and Tolerance in First and Later Lines of Enzalutamide Treatment for Metastatic Castration-resistant Prostate Cancer: A Real-World Experience in Hong Kong. Clin Genitourin Cancer. 2018 Oct;16(5):402-412.e1. doi: 10.1016/j.clgc.2018.07.008. Epub 2018 Jul 21.
PMID: 30126765DERIVEDHeller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.
PMID: 29272162DERIVEDAntoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.
PMID: 26278649DERIVEDGibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.
PMID: 25917876DERIVEDCella D, Ivanescu C, Holmstrom S, Bui CN, Spalding J, Fizazi K. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial. Ann Oncol. 2015 Jan;26(1):179-185. doi: 10.1093/annonc/mdu510. Epub 2014 Oct 30.
PMID: 25361992DERIVEDSaad F, de Bono J, Shore N, Fizazi K, Loriot Y, Hirmand M, Franks B, Haas GP, Scher HI. Efficacy outcomes by baseline prostate-specific antigen quartile in the AFFIRM trial. Eur Urol. 2015 Feb;67(2):223-30. doi: 10.1016/j.eururo.2014.08.025. Epub 2014 Aug 27.
PMID: 25171902DERIVEDMerseburger AS, Scher HI, Bellmunt J, Miller K, Mulders PF, Stenzl A, Sternberg CN, Fizazi K, Hirmand M, Franks B, Haas GP, de Bono J, de Wit R. Enzalutamide in European and North American men participating in the AFFIRM trial. BJU Int. 2015 Jan;115(1):41-9. doi: 10.1111/bju.12898. Epub 2014 Oct 23.
PMID: 25123978DERIVEDFizazi K, Scher HI, Miller K, Basch E, Sternberg CN, Cella D, Forer D, Hirmand M, de Bono JS. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol. 2014 Sep;15(10):1147-56. doi: 10.1016/S1470-2045(14)70303-1. Epub 2014 Aug 4.
PMID: 25104109DERIVEDScher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15.
PMID: 22894553DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The primary objectives (overall survival) of the study had been met and all participants who had remained on study treatment have discontinued and therefore the study has been considered as completed.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2009
First Posted
September 10, 2009
Study Start
September 30, 2009
Primary Completion
September 15, 2011
Study Completion
November 2, 2017
Last Updated
December 11, 2018
Results First Posted
October 30, 2012
Record last verified: 2018-11